Spineart SA, manufacturer of the BAGUERA®C Cervical Disc Prosthesis, is delighted to announce completion of enrollment in its U.S. IDE trial studying the BAGUERA®C Cervical Disc Prosthesis in patients with single-level cervical disc disease between C3 to C7 compared to a commercially marketed cervical disc implant.
“We would like to thank all the investigators, their staff and the patients participating in the BAGUERA®C trial for their dedication and support,” said Jerome Trividic, chief executive officer of Spineart. “We are committed to advancing spine arthroplasty worldwide and establishing BAGUERA®C as a leading motion preserving technology for US surgeons and their patients.”
Hyun W. Bae, MD, with the Spine Institute, Santa Monica, CA and one of the lead investigators for the study, said, “Cervical Disc Arthroplasty is becoming the preferred option in the treatment of degenerative disc disease as it allows to achieve decompression of the nerves, while preserving physiologic segmental motion. I am excited to continue following up my patients in the BAGUERA®C IDE study and confirming the initial positive outcomes we have collected so far.”
The BAGUERA®C Cervical Disc Prosthesis has been commercially available in selected European and worldwide markets since 2008 with over 60,000 implants sold.
SOLCO BIOMEDICAL HAS BEEN OFFICIALLY APPOINTED AS OUR NEW EXCLUSIVE DISTRIBUTOR FOR BAGUERA® C IN THE REPUBLIC OF KOREA.
On September 1st, 2023, Spineart SA entered into a distribution agreement with Solco Biomedical of Republic of Korea. Since January 1st, 2024, Solco is the sole distributor of BAGUERA® C, with exclusive commercialization rights in the Republic of Korea.
This partnership combines over 12 years of BAGUERA® C clinical experience with Solco’s extensive distribution network and 50 years of presence in the medical device environment.
Spineart is a privately held medical device company focused on simplifying the surgical act by designing, developing, and promoting safe and efficient solutions to spine surgeons, operating room teams, and patients. Spineart markets a complete portfolio, in 60 markets, combining traceable barcoded sterile packed implants with compact instrument sets, thus proudly promoting greater safety, cost-efficiency, and compliance at the hospital.
Established in 1974, Solco Biomedical manufactures and distributes a wide range of medical devices and is listed on the KOSDAQ since 2000.
We are building a new factory and broke ground on October 26th, 2023.
Built on a 7,000 sqm (70,000 sqft) greenfield development lot, the new Spineart factory is our third production site and our largest so far with more than 4,200 sqm (42,000 sqft) and will eventually regroup all our manufacturing and logistics activities. It will be equipped with state-of-the-art additive manufacturing, CNC machines and a new clean room. This new site will support Spineart continued double-digit growth through a significant manufacturing footprint expansion and the integration of the latest manufacturing innovations as well as sustainability standards.
The new factory is located close to our global headquarters in Geneva, Switzerland, in a region renowned for being a center of excellence for precision manufacturing.
The official opening of the new Spineart factory is scheduled early 2025.
For the first time in its history, Spineart has reached and surpassed €100m of trailing 12-month revenue.
As the success and expansion of the Ti-LIFE ranges continues, we are rolling out the posterior fixation PERLA® platform and actively invest and develop multiple enabling technologies for spine surgeries, as exemplified by its co-development agreement with eCential robotics.
We are steadily gaining market share in Europe where the MDR certification of our full portfolio is well ahead of our peers and in the US through the addition of state-of-the-art systems to our portfolio. Our 2 US IDE trials for the BAGUERA® C cervical disc prothesis are enrolling at full speed and we are aiming for enrollment completion in the coming months. Meanwhile the 10-year safety and efficacy data for BAGUERA® C collected from Europe have been published in the prestigious European Spine Journal.
Spineart is committed to transform spine surgery for patients, surgeons and hospitals as we aim to create safe solutions and ultimately advance healthcare worldwide.
For the first time in its history, Spineart has organized an exclusive event for women in the Spine industry in Luzern, Switzerland last week.
The goal of this program was to offer women spine surgeons a dedicated platform to advance the dialogue on important spine topics, make lasting connections and inspire each other.
Considering the quality of the exchanges between the 22 participants who addressed scientific subjects but also discussed how to strengthen the science ecosystem together, we are delighted to share that the mission was accomplished!
We would like to thank all our special guests Susanne Siegenthaler, Military pilot in the Swiss Air Force, Dr. Med. Nermine Habib, Founder and President of Swiss Female Orthopaedics, Dr. Adéla Wyncoll, Co-Founder and managing partner of Women’s Leadership Academy and Dr. Med. Dominique Kuhlen, Chief Clinical Officer of the Hirslanden Group. A special thanks also goes to our speakers Dr. Caroline Hirsch, Dr. Sara Burguet, Dr. Lima Sprenger, Dr. Sonja Häckel and Dr. Raluca Reitmeier and to all the participants.
We are absolutely certain that this event will be the first of a long list and we can’t wait for the next editions!
After the 5-Year clinical results published in 2018, we are proud to announce that the European Spine Journal has just published the 10-Year results.
81 patients continued their follow up to 10-years and the results confirm the long-term performance and safety of the device. In a nutshell, at 10 years the range of motion is preserved in 86.6% of the patients, the upper adjacentdisc height is preserved with no degeneration, compared with the pre-operative height. There are no long-term device or surgery related complications and no progressive osteolysis is observed.
We look forward to seeing the 15-Year results!